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SchizophreniaPhase 4CARE IINCT00681629

Schizophrenic Patients in Integrated Care

A Phase 4 study testing Quetiapine XR and Integrated Care Program (ICP) in people with Schizophrenia and Schizoaffective Disorder, run by AstraZeneca at 8 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of the study is to investigate the well-being of schizophrenic patients treated with quetiapine XR combined with participation in the integrated care program compared to a treatment with quetiapine XR alone over a period of 18 month Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Quetiapine XR and Integrated Care Program (ICP)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
8 sitesGermany
Study dates
Jul 2008to Nov 2008
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with baseline SWN-K <=70
  • Provision of signed informed consent
  • Out-patients with schizophrenia, schizophreniform disorder or schizoaffective disorder, severe postpartum depressive disorders with psychotic symptoms and a minimum HAM-D cut off score of 20 points

Who cannot join

  • Evidence of a clinical relevant disease, eg renal or hepatic impairment, significant coronary heart disease, hepatitis B or C, AIDS
  • Patients with known cardiovascular disease or other condition predisposing to hypotension or family history of QT prolongation
  • Patients who pose an imminent risk of suicide or danger to self or others

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Germany8 sites
  • Research Site

    Berlin, State of Berlin

  • Research Site

    Chemnitz, Saxony

  • Research Site

    Hamburg, Free and Hanseatic City of Hamburg

  • Research Site

    Lüneburg, Lower Saxony

  • Research Site

    München, Bavaria

  • Research Site

    Oldenburg, Lower Saxony

  • Research Site

    Oranienburg, Brandenburg

  • Research Site

    Stolberg

Other trials in Germany

About this study

Official title: CARE II - Evaluation of Treatment Outcomes in Schizophrenic Patients Taking Part in the Integrated Care Program - a Single-country, Multi-centre Phase IV Study

The purpose of the study is to investigate the well-being of schizophrenic patients treated with quetiapine XR combined with participation in the integrated care program compared to a treatment with quetiapine XR alone over a period of 18 month

Being tested
Quetiapine XR, Integrated Care Program (ICP)
Keywords
Schizophrenia, Integrated Care, Quetiapine
Medical subject headings
Schizophrenia, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Quetiapine XRDrug

    Also called Seroquel Prolong

    400-800 mg, oral, bid

  • Integrated Care Program (ICP)Other

    Integrated care program (ICP), this is a legally based integrated care program covered by a contract according to §§ 140 a-d SGB-V (SGB: social security code); The ICP is not exclusively designed for this phase IV trial. Participation in the ICP is possible anytime for each patient in whom the services are covered by the individual health insurance.

Study groups in NCT00681629
Study groupRoleWhat they receive
Quetiapine XR AloneExperimentalOral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
Receives: Drug: Quetiapine XR
Quetiapine XR With Integrated Care Program (ICP)ExperimentalOral administration as 200 mg and 300 mg tablets allowing flexible dosing in 100 mg steps. Once daily in the evening. On day 1: 300 mg quetiapine XR, on day 2 : 600 mg, from day 3 onwards 400 to 800 mg at the centre-specific investigator´s discretion
Receives: Drug: Quetiapine XR; Other: Integrated Care Program (ICP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Subjective Well-being in Patients Treated for Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Delusional Disorder or Psychotic Disorder Not Otherwise Specified Using the SWN-K (Subjective Well-being Under Neuroleptics) Scale

    The SWN-K is comprised of 20 questions, each of which is rated using a 6 point scale ranging from 1 (not at all) to 6 (very much). Possible scores range from 20-120, with higher scores implying higher subjective well-being.

    Measured: 4 months

Secondary outcomes (19)
  1. Subjective Well-being Using the SWN-K (Subjective Well-being Under Neuroleptics Scale) Total Score

    The SWN-K is comprised of 20 questions, each of which is rated using a 6 point scale ranging from 1 (not at all) to 6 (very much). Possible scores range from 20-120, with higher scores implying higher subjective well-being.

    Measured: 4 month

  2. Symptomatic Outcome Using CGI-S (Clinical Global Impression-Schizophrenia) Scale

    With the CGI-S the rate of the severity of a patient's symptoms (positive, negative, cognitive, depressive and overall) using a scale ranging from 1 (normal, not ill) to 7 (among the most severely ill) is measured - higher scores implying higher severity.

    Measured: 4 month

  3. Symptomatic Outcome Using the PANSS-8 Scales(Positive and Negative Symptoms) Scale Score

    The schizophrenic symptomatology will be measured by the Positive and Negative Syndrome Scale (PANSS) providing 8 items of which each is rated on a severity scale ranging from 1-7, (1= absent - 7 = extreme severe. higher scores implying higher severity.

    Measured: 4 month

  4. GAF (Global Assessment of Functioning) Scale Score

    The "GAF" is a numeric rating scale used by clinicians for assessment of the social, occupational, psychological functioning of adult patients. The scale represents a hypothetical continuum of mental health illness providing a descending scoring code from 100 until 0. Higher scores indicate better patient condition and performance.

    Measured: 4 month

  5. PSP (Personal and Social Performance) Scale Score

    The '(PSP" rating scale (100 until 0) used by clinicians for assessment of 4 main domains of functioning in adult patients acc. (a) socially useful activities including work and study, (b) personal and social relationships, (c) self-care, and (d) disturbing and aggressive behavior. Higher scores indicate better patient condition and performance.

    Measured: 4 month

  6. EQ-5D (European Quality of Life Questionnaire) Score

    The EQ-5D questionnaire is a generic measure of health status. It defines health in terms of five dimensions:1 (Mobility); 2 (Self-care); 3 (Usual activity); 4 (Pain/Discomfort); 5 (Anxiety/Depression).

    The minimum possible value is 5 (one point for each dimension) and the maximum possible values is 15 (3 points for each dimension). Each dimension has 3 levels of "severity"- "no problems, "some problems" and "extreme problems". Higher scores indicate more problems.

    Measured: 4 month

  7. Vocational Occupational Index "VOC" Score

    The "VOC" index will assess the following 7 items: 1 fulltime gainful employment, 2 homemaker or student, 3 part-time gainful employment (20 hours per week or less), 4 retired, 5 full or part-time volunteer, 6 on medical or psychiatric leave of absence, 7 unemployed, whether or not expected to work. Results will be descriptively summarized. The VOC index will be completed at each visit. Difference from baseline of the index will be derived at each assessment

    Measured: Up to 18 months (V1 Day 1, V2 Month 1, V3 Month 3, V4 Month 6, V5 Month 12, V6 Month 18)

  8. Assess Quality of Life Levels Using the Q-LES-Q-18 (Quality of Life Enjoyment and Satisfaction) Questionnaire

    Q-LES-Q-18 will allow to generate a general QoL-index which will be used for the analysis and is defined as the average of the single scores for all 18 items. Scoring will be carried out from 1-5 per item (never / rarely / sometimes / frequently / all the time). Results will be descriptively summarized.

    Measured: 4 month

  9. Assess Quality of Life Levels Using the RSM Scale (Riedel-Spellmann-Musil) Scale

    The '(RSM" is a new 36-item measure validated to assess the "QoL" in different dimensions of schizophrenic patient treated with antipsychotics. It will be rated on a four-point Likert scale (not / rather not / rather yes / yes) by the patient and the investigator. The total score ranges from min. 0 to max. of 108. Higher scores indicate higher "QoL".

    Measured: 4 month

  10. Assess Patient Engagement to Therapy Using the SES Scale (Service Engagement Scale)

    The 'SES" is a 14-item measure consisting of statements that assess the client specific engagement with services. It will be rated on a four-point Likert scale (not at all / rarely / sometimes / most of the time) by the investigator. The total score ranges from min. 0 to a max. of 42. Higher scores indicate lower engagement.

    Measured: 4 month

  11. Assess Compliance/Medication Adherence Using the MARS Scale (Medication Adherence Rating Scale)

    The 'Medication Adherence Rating Scale' (MARS) is a reliable and valid self-reporting tool for investigation of the compliance in psychiatric patients also recognizing the complexity of compliance behaviour. 10 questions on medication attitude have to be answered by 'yes' or 'no' (8 times 1= no and Yes = 0 and twice 1= no, Yes =1). Results will be descriptively summarized. Summarized results minimum 0: low medication adherence, maximum 10: high medication adherence.

    Measured: 4 month

  12. Evaluate the Level of the Patients' (Subjective) Satisfaction Using the CSQ-8 Scale (Client Satisfaction Questionnaire)

    The 'CSQ-8" is a brief, self-administered method to monitor the consumer's satisfaction with services in outpatient psychotherapy, showing high internal consistency. It is identified as a core subset of the general CSQ covering 8 Likert-type items with four response choices where '1' indicates the lowest and '4' the highest degree of satisfaction.

    Measured: 4 month

  13. Assess Health Economy Improvements in Terms of a Reduction in Treatment Costs and Loss of Productivity by Determination of the Total Cost by Number of Days With Hospitalization

    Any hospitalisation days in inpatients units and emergency ward stays will be recorded. At each hospitalisation, the number of days will be computed and at each visit, the cumulative total number of days will be used to calculate total costs. As higher the number of hospitalisation days as higher the costs per patient.

    Measured: 4 month

  14. Assess Health Economy Improvements in Terms of a Reduction in Treatment Costs and Loss of Productivity by Determination of the Total Number of Days the Patient Was Not Able to Work or go to School or Complete Routine Daily Activities

    The number of lost work days, lost school days or days without completing routine daily activities will be evaluated. With any number of lost workdays or lost school days or without completing routine daily activities, the costs will increase and the productivity will decrease.

    Measured: 4 month

  15. Assess Health Economy Improvements in Terms of a Reduction in Treatment Costs and Loss of Productivity by Determination of the Need for Any Additional Antipsychotic Medication

    Concomitant psychotropic drugs will be coded (ATC = Drug code) to allow a comparison of the number of drugs used per ATC class and per treatment visit. The drugs used will be listed by keeping their brand name for allowing to translate them into costs.

    Measured: 4 month

  16. Evaluate Safety and Tolerability by Evaluation of Weight/Waist Circumference

    Measuring of weight and waist circumference in centimeter.

    Measured: 4 month

  17. Evaluate Safety and Tolerability by Evaluation of Laboratory Tests

    Measuring of: B-Haemoglobin (g/dl), B-Haematocrit(%), B-Erythrocyte count(pl), B-Leucocytes count (nl), B-Platelet count(nl), Complete blood count (nl), B-Leucocytes differential count (%), B-HbA1c(%), S-ALAT (U/l), S-ASAT (U/l), S-GGT (U/l), P-Glucose (fasting)(mh/dl), S-prolactin level (ng/ml), S-Pregnancy test (IU/l), Qualitative analysis of urine with Stix®,Urine pregnancy. Comparing results with standard values.

    Measured: 4 month

  18. Evaluate Safety and Tolerability by Evaluation of Concomitant Medication

    Listing of all concomitant medication to show the efficacy and safety.

    Measured: 4 month

  19. Evaluate Safety and Tolerability by Evaluation of the Incidence of Adverse Events

    Listing of all adverse event or SAE´s to show the safety and tolerability.

    Measured: 4 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 May 2008 (estimated)
  2. Study startJul 2008
  3. Primary completionNov 2008
  4. Study completionNov 2008

Why it stopped: Difficulty finding eligible sites/patients; current situation in health policy cause negative effect on existing/planned contracts for integrated care program

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00681629
Sponsor's protocol ID
D1443L00048
Acronym
CARE II
Status last verified
Jun 2012
First submitted
20 May 2008
Last updated
30 Jul 2012
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Quetiapine XR and Integrated Care Program (ICP) in people with Schizophrenia and Schizoaffective Disorder, run by AstraZeneca at 8 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 30 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jul 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjective Well-being in Patients Treated for Schizophrenia, Schizoaffective Disorder, Schizophreniform Disorder, Delusional Disorder or Psychotic Disorder Not Otherwise Specified Using the SWN-K (Subjective Well-being Under Neuroleptics) Scale (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2012.

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